—#104415

Product

ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood Distributed by Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1L75-25. The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver and kidney transplant patients receiving cyclosporine therapy.

FDA product code: MKW — Cyclosporine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K080751
Affected lot / code info: lots 95098M500 exp 12/21/2011; 96143M500 exp 01/20/2012; 96142M500 exp 01/20/2012; 01107M500 exp 02/24/2011; 02079M500 exp 02/24/2012; 03182M500 exp 05/19/2012; 05533M500 exp 05/19/2012; 04069M500 exp 06/02/2012; 06525M500 exp 06/02/2012; 05014M500 exp 06/23/2012; 07011M500 exp 06/23/2012

Why it was recalled

The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have the potential to be impacted by the assay imprecision.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Abbott Laboratories sent a "PRODUCT RECALL" letter dated October 7, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to only run ARCHITECT Cyclosporine using Reaction Vessel (RV) lots manufactured with the same resin as follows: a) RV lots beginning with lot 06083P100 and higher can be used together or, b) RVs lots lower than 06083P100 can be used together. Any RV lot number that does not begin with a zero (e.g. 90032P100) should also be considered lower than 06083P100. Further instructions were included for the accounts to follow when running ARCHITECT Cyclosporine assays. A Customer Reply form was provided to customers to complete and return via fax at 1-800-777-0051. Customers can contact Abbott Customer Service at 1-877-4ABBOTT for questions regarding this notice. A second letter was sent to the accounts on 11/23/11 to simplify the instructions for identifying the Architect Reaction Vessel lots that can be used together for use with the Architect Cyclosporine assay.

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Vietnam.

Timeline

Recall initiated: 2011-10-07
Posted by FDA: 2011-11-04
Terminated: 2012-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104415. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.